[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Rules and Regulations]
[Pages 12083-12088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2011-N-0103]
RIN 0910-AH98


Microbiology Devices; Classification of In Vitro Diagnostic 
Devices for Bacillus Species Detection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
issuing a final rule to classify in vitro diagnostic devices for 
Bacillus species (spp.) detection into class II (special controls) and 
to continue to require a premarket notification (510(k)) to provide a 
reasonable assurance of safety and effectiveness of the device. FDA is 
also establishing special controls in a special controls guideline in 
addition to restricting use and distribution of the devices. An in 
vitro diagnostic device for Bacillus spp. detection is a prescription 
device used to detect and differentiate among Bacillus spp. and 
presumptively identify B. anthracis and other Bacillus spp. from 
cultured isolates or clinical specimens as an aid in the diagnosis of 
anthrax and other diseases caused by Bacillus spp.

DATES: This rule is effective May 1, 2019. See further discussion in 
section V ``Implementation Strategy''.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beena Puri, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4502, Silver Spring, MD 20993-0002, 301-796-6202. 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

[[Page 12084]]

    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
V. Implementation Strategy
VI. Electronic Access
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Final Rule

    FDA is classifying in vitro diagnostic devices for Bacillus species 
(spp.) detection (product codes NVQ, NPO, NRL, NHT, and NWZ) into class 
II (special controls), establishing special controls in a special 
controls guideline entitled ``Class II Special Controls Guideline: In 
Vitro Diagnostic Devices for Bacillus spp. Detection,'' restricting the 
device to prescription use, and restricting distribution of these 
devices to laboratories that follow public health guidelines that 
address appropriate biosafety conditions, interpretation of test 
results, and coordination of findings with public health authorities.
    This decision is based upon the recommendations from the 
Microbiology Devices Advisory Panel (the Panel), public comments 
received following the publication of the proposed rule, FDA's 
experience with these devices. FDA believes that the special controls 
established and imposed by this final rule and special controls 
guideline, together with the general controls, will provide a 
reasonable assurance of safety and effectiveness of the device. 
Further, FDA believes that the restrictions on use and distribution are 
required for the safe and effective use of the device.

B. Summary of the Major Provisions of the Final Rule

    This final rule classifies in vitro diagnostic devices for Bacillus 
spp. detection into class II (special controls), and establishes 
special controls in a special controls guideline entitled ``Class II 
Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus 
spp. Detection'' which address: (1) Specific information relating to 
the devices' intended use, components, testing procedures, specimen 
storage/shipping conditions, and interpretation/reporting; (2) detailed 
descriptive information regarding the studies required to demonstrate 
appropriate performance and control against assays that may otherwise 
fail to perform to acceptable standards; (3) specific labeling 
requirements; and (4) certain information that must be submitted for in 
vitro diagnostic devices for Bacillus spp. detection that use nucleic 
acid amplification.
    This rule also restricts the use and distribution of these devices. 
Because handling the quality control organisms and those potentially 
present in the specimen may pose a risk to laboratory workers, FDA is 
finalizing a restriction on distribution of these products to 
laboratories that follow public health guidelines that address 
appropriate biosafety conditions, interpretation of test results, and 
coordination of findings with public health authorities. Further, FDA 
is restricting use of these devices to be a prescription device under 
the terms set forth in 21 CFR 866.3045(d).

C. Legal Authority

    FDA is issuing this rule under the authority of the provisions of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to 
medical devices (21 U.S.C. 301 et seq.), including section 513(a) 
regarding device classes (21 U.S.C. 360c(a)), sections 513(b) and (c) 
regarding device classification panels (21 U.S.C. 360c(b) and (c)), 
section 513(d) regarding device classification (21 U.S.C. 360c(d)), and 
section 520(e) regarding restrictions on the sale, distribution, or use 
of a device (21 U.S.C. 360j(e)).

D. Costs and Benefits

    Quantifiable benefits of this rule are annual cost savings 
resulting from a reduction in the time burden of inquiries 
manufacturers submit to FDA. The primary present value of the benefits, 
over a 20-year time horizon from 2018 to 2038 are estimated to be 
$258,054, at a 7 percent discount rate and $353,393, at a 3 percent 
discount rate. The primary estimate of the annual benefits is $22,258 a 
year.
    This rule has a one-time upfront cost for current manufacturers of 
these devices as they will need to spend time reading the rule and may 
need to develop new labeling. There is also an annual cost of reading 
the rule to firms who may submit inquiries in the future. The primary 
present value of the costs, over a 20-year time horizon, are estimated 
to be $12,659 at a 7 percent discount rate and $14,081 at a 3 percent 
discount rate. The primary annualized costs are $1,092 at a 7 percent 
discount rate and $887 at a 3 percent discount rate. The total net 
benefit of the rule is estimated to be $245,395 at a 7 percent discount 
rate and $339,312 at a 3 percent discount rate. The annualized net 
benefits of this rule are estimated to be $21,166 at a 7 percent 
discount rate and $21,371 at a 3 percent discount rate.

II. Background

A. History of This Rulemaking

    In the Federal Register of November 17, 2015 (80 FR 71756), FDA 
issued a proposed rule to classify in vitro diagnostic devices for 
Bacillus spp. detection as class II with special controls, and proposed 
the draft special controls guideline entitled ``Class II Special 
Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. 
Detection; Draft Guideline for Industry and Food and Drug 
Administration Staff'' (Ref. 1) and certain restrictions on its use and 
distribution. The proposed special controls and restrictions were 
based, in part, upon feedback received from the Panel on March 7, 2002 
(Ref. 2). FDA invited interested persons to comment on the proposed 
regulation and the special controls guideline by February 16, 2016.

B. Summary of Comments to the Proposed Rule

    FDA received one comment requesting an exclusive 510(k). This 
comment is outside the scope of the rule. No comments opposed the 
proposed classification for in vitro diagnostic devices for Bacillus 
spp. detection.

III. Legal Authority

    The FD&C Act (21 U.S.C. 301 et seq.), as amended, established a 
comprehensive system for the regulation of medical devices intended for 
human use. The FD&C Act establishes three categories (classes) of 
devices, reflecting the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness (section 513(a) 
of the FD&C Act). The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Class I devices are those devices for which the general controls of 
the FD&C Act (controls authorized by or under the general controls 
sections of the FD&C Act (sections 501, 502, 510, 516, 518, 519, or 520 
(21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j), or any 
combination of such sections) are sufficient to provide a reasonable 
assurance of the safety and effectiveness of the device; or those 
devices for which insufficient information exists to determine that 
general controls are

[[Page 12085]]

sufficient to provide reasonable assurance of the safety and 
effectiveness of the device or to establish special controls to provide 
such assurance, but because the devices are not purported or 
represented to be for a use in supporting or sustaining human life or 
for a use which is of substantial importance in preventing impairment 
of human health, and do not present a potential unreasonable risk of 
illness or injury, are to be regulated by general controls (section 
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for 
which general controls by themselves are insufficient to provide 
reasonable assurance of the safety and effectiveness, and for which 
there is sufficient information to establish special controls to 
provide such assurance, including the promulgation of performance 
standards, postmarket surveillance, patient registries, development and 
dissemination of guidelines, recommendations, and other appropriate 
actions as the Agency deems necessary to provide such assurance 
(section 513(a)(1)(B) of the FD&C Act). Class III devices are those 
devices for which insufficient information exists to determine that 
general controls and special controls would provide a reasonable 
assurance of safety and effectiveness, and are purported or represented 
for a use in supporting or sustaining human life or for a use which is 
of substantial importance in preventing impairment of human health, or 
present a potential unreasonable risk of illness or injury (section 
513(a)(1)(C) of the FD&C Act).
    FDA refers to devices that were in commercial distribution before 
May 28, 1976 (the date of enactment of the Medical Device Amendments of 
1976), as ``preamendments devices.'' Pursuant to section 513(d)(1) of 
the FD&C Act, FDA classifies these devices after FDA: (1) Receives a 
recommendation from a device classification panel (an FDA advisory 
committee); (2) publishes the panel's recommendation for comment, along 
with a proposed regulation classifying the device; and (3) publishes a 
final regulation classifying the device (section 513(d)(1) of the FD&C 
Act). FDA has classified most preamendments devices under these 
procedures and has followed these procedures to classify in vitro 
diagnostic devices for Bacillus spp. detection.
    Section 520(e) of the FD&C Act authorizes FDA to issue regulations 
imposing restrictions on the sale, distribution, or use of a device, if 
because of its potentiality for harmful effect or the collateral 
measures necessary to its use, FDA determines that absent such 
restrictions, there cannot be a reasonable assurance of its safety and 
effectiveness. Certain provisions of the FD&C Act related specifically 
to FDA's authority over restricted devices. For example, section 502(q) 
and (r) of the FD&C Act provide that a restricted device distributed or 
offered for sale in any state shall be deemed to be misbranded if its 
advertising is false or misleading or fails to include certain 
information regarding the device, or it is sold, distributed, or used 
in violation of regulations prescribed under section 520(e) of the FD&C 
Act, and section 704(a) of the FD&C Act (21 U.S.C. 374(a)) authorizes 
FDA to inspect certain records relating to restricted devices. FDA 
continues to believe that the restrictions as provided in the final 
rule related to distribution and use are required for the safe and 
effective use of the device.

IV. Comments on the Proposed Rule and FDA Response

    FDA received one comment on the proposed rule by the close of the 
comment period, requesting an exclusive 510(k). This comment is outside 
of the scope of the rule. No comments opposed the proposed 
classification for in vitro diagnostic devices for Bacillus spp. 
detection. In this final rule, FDA is adopting the classification, 
special controls and the restrictions on use and distribution from its 
proposed rule published on November 17, 2015 (80 FR 71756).

V. Implementation Strategy

    This final rule will become effective 30 days after its date of 
publication in the Federal Register.
    The implementation strategy is set forth below for these devices.
     Devices that have not been legally marketed prior to the 
date of publication of this final rule, or devices that have been 
legally marketed, but are required to submit a new 510(k) under 21 CFR 
807.81(a)(3) because the device is about to be significantly changed or 
modified: Manufacturers must obtain 510(k) clearance and comply with 
special controls before marketing the new or changed device.
     Devices that have been legally marketed prior to the date 
of publication of this final rule, and devices for which 510(k) 
submissions have been submitted before the date of publication of this 
final rule: Manufacturers are not required to submit a 510(k) to 
demonstrate compliance with the special controls set forth in sections 
VI, VII, and IX of the special controls guideline. FDA had proposed 
that manufacturers of such devices must comply with the underlying 
requirements for those special controls, as well as the labeling 
special controls set forth in section VIII of the special controls 
guideline. FDA is finalizing our classification and is clarifying that 
for such devices, FDA does not expect submission of documentation to 
FDA demonstrating compliance with the special controls set forth in 
sections VI, VII, and IX of the special controls guideline. Further, 
FDA does not intend to enforce compliance with the labeling special 
controls set forth in section VIII of the special controls guideline 
until April 1, 2020. If a manufacturer markets such a device after 
April 1, 2020, and that device does not comply with the labeling 
special controls set forth in section VIII of the special controls 
guideline, then FDA would consider taking action against such a 
manufacturer under its usual enforcement policies. FDA believes that a 
period of 1 year from the publication date of this final rule is 
appropriate for manufacturers to come into compliance with such 
requirements. FDA believes this approach will help ensure the efficient 
and effective implementation of this final rule.

VI. Electronic Access

    Persons interested in obtaining a copy of the final special 
controls guideline may do so by using the internet. A search capability 
for all Center for Devices and Radiological Health guidelines and 
guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocumentsdefault.htm. The final 
special controls guideline is also available at https://www.regulations.gov. Persons unable to download an electronic copy of 
``Class II Special Controls Guideline: In Vitro Diagnostic Devices for 
Bacillus spp. Detection,'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1400038 to identify the special controls 
guideline you are requesting.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety,

[[Page 12086]]

and other advantages; distributive impacts; and equity). Executive 
Order 13771 requires that the costs associated with significant new 
regulations ``shall, to the extent permitted by law, be offset by the 
elimination of existing costs associated with at least two prior 
regulations.'' We believe that this final rule is not a significant 
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because of the small impact expected from this rule, we 
certify that the final rule will not have a significant economic impact 
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $154 million, using the most current (2018) Implicit 
Price Deflator for the Gross Domestic Product. This final rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    Quantifiable benefits of this rule are cost savings resulting from 
a reduction in the time burden of inquiries manufacturers submit to 
FDA. The cost savings involve manufacturers, who no longer need to 
submit as many inquiries related to submissions for these devices, 
because much of the necessary information is provided by this rule and 
guideline, and FDA, who no longer needs to use resources to respond to 
these inquiries. A 20-year time horizon was chosen for this analysis 
because this industry has been stable and there is no reason to expect 
disruptions for the foreseeable future. The primary present value of 
the benefits, over a 20-year time horizon from 2018 to 2038 are 
estimated to be $258,054, at a 7 percent discount rate and $353,393, at 
a 3 percent discount rate. The primary estimate of the annual benefits, 
over a 20-year time horizon from 2018 to 2038, are estimated to be 
$22,258 a year.

              Table 1--Summary of Benefits, Costs, and Distributional Effects of the Final Rule in 2017 Dollars Over a 20-Year Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Units
                                     Primary                                    ------------------------------------------------
            Category                estimate      Low estimate    High estimate                   Discount rate                           Notes
                                                                                  Year dollars         (%)       Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $/year         $22,258          $7,419         $37,096            2017               7              20
                                         22,258           7,419          37,096            2017               3  ..............
    Annualized Quantified......  ..............  ..............  ..............  ..............               7  ..............
                                 ..............  ..............  ..............  ..............               3  ..............
    Qualitative.
Costs:
    Annualized Monetized $/year           1,092             733           1,455            2017               7              20
                                            887             595           1,183            2017               3              20
    Annualized Quantified......  ..............  ..............  ..............  ..............               7  ..............
                                 ..............  ..............  ..............  ..............               3  ..............
    Qualitative.
Transfers:
    Federal Annualized           ..............  ..............  ..............  ..............               7  ..............
     Monetized $/year.           ..............  ..............  ..............  ..............               3  ..............
                                ------------------------------------------------------------------------------------------------------------------------
    From/To....................  From:
                                 To:
                                ------------------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized   ..............  ..............  ..............  ..............               7  ..............
     $/year.                     ..............  ..............  ..............  ..............               3  ..............
                                ------------------------------------------------------------------------------------------------------------------------
    From/To....................  From:
                                 To:
                                ------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:
    Small Business:
    Wages:
    Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    This rule has a one-time upfront cost for current manufacturers of 
these devices as they may need to develop new labeling. There are seven 
total products on the market and each labeling redesign is estimated to 
cost $1,096. We estimate the total labeling cost to be $7,674. The six 
existing manufacturers (one firm has two products) also face a one-time 
upfront cost of having to read the rule and guideline which we estimate 
to be $1,138 for the manufacturers. Finally, there is an annual cost of 
reading the rule to firms who may submit inquiries in the future. We 
estimate this annual cost to be $332. The primary present value of the 
costs, over a 20-year time horizon from 2018 to 2038, are estimated to 
be $12,659 at a 7 percent discount rate and $14,081 at a 3 percent 
discount rate. The primary annualized costs, over a 20-year time 
horizon from 2018 to 2038, are estimated to be $1,092 at a 7 percent 
discount rate and $887 at a 3 percent discount rate. The total net 
benefit of the rule is estimated to be $245,395 at a 7 percent discount 
rate and $339,312 at a 3 percent discount rate. The annualized net 
benefits of this rule are estimated to be $21,166 at a 7 percent 
discount rate and $21,371 at a 3 percent discount rate.
    In line with Executive Order 13771, in table 2 we estimate present 
and annualized values of costs and cost savings over an infinite time 
horizon. Based on these cost savings this final rule would be 
considered a deregulatory action under Executive Order 13771. Our 
primary estimate for the present value of the net costs is -$319,974 
(or a cost savings of $319,974) at a 7 percent discount rate and -
$729,462 at a 3 percent discount rate in 2016 dollars.

[[Page 12087]]



                                                      Table 2--Executive Order 13771 Summary Table
                                                    [In 2016 dollars, over an infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................         $13,614          $9,133         $18,094         $19,812         $13,265         $26,358
Present Value of Cost Savings...........................         333,588          77,548         555,938         749,273         174,181       1,248,789
Present Value of Net Costs..............................       (319,974)        (68,415)       (537,843)       (729,462)       (160,916)     (1,222,430)
Annualized Costs........................................             891             597           1,184             577             386             768
Annualized Cost Savings.................................          21,823           5,073          36,370          21,823           5,073          36,372
Annualized Net Costs....................................        (20,933)         (4,476)        (35,186)        (21,246)         (4,687)        (35,605)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 3) and at 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final rule establishes special controls and restrictions that 
refer to currently approved collections of information found in other 
FDA regulations. These collections of information are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections 
of information in 21 CFR part 807, subpart E, have been approved under 
OMB control number 0910-0120 and the collections of information in 21 
CFR parts 801 and 809 have been approved under OMB control number 0910-
0485.
    The labeling referenced in sections VI(A), VIII(A), and VIII(C) of 
the final special controls guideline do not constitute a ``collection 
of information'' under the PRA because the labeling is a ``public 
disclosure of information originally supplied by the Federal government 
to the recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

XI. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have a copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

*1. Final Special Controls Guideline for Industry and Food and Drug 
Administration Staff, ``Class II Special Controls Guideline: In 
Vitro Diagnostic Devices for Bacillus spp. Detection,'' issued April 
1, 2019, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM470760.pdf.
*2. Transcript of the FDA Microbiology Devices Panel meeting, March 
7, 2002 (available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=348).
*3. ``Preliminary Regulatory Impact Analysis, Initial Regulatory 
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for 
Microbiology Devices; Classification of In Vitro Diagnostic Device 
for Bacillus Species Detection,'' available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM477856.pdf.
4. Abshire, T.G., J.E. Brown, and J.W. Ezzell, ``Validation of the 
Use of Gamma Phage for Identifying Bacillus anthracis,'' 102nd 
American Society for Microbiology Annual Meeting (poster #C122), 
2001.
*5. Abshire, T.G., et al., ``Production and Validation of the Use of 
Gamma Phage for the Identification of Bacillus anthracis,'' Journal 
of Clinical Microbiology, vol. 43(9), pp. 4780-8, 2005, available at 
https://www.ncbi.nlm.nih.gov/pubmed/16145141.
* 6. Brown, E.R. and W.B. Cherry, ``Specific Identification of 
Bacillus anthracis by Means of a Variant Bacteriophage,'' Journal of 
Infectious Diseases, vol. 96, p. 34, 1955, available at https://jid.oxfordjournals.org/content/96/1/34.long.
* 7. Brown, E.R. et al., ``Differential Diagnosis of Bacillus 
cereus, Bacillus anthracis, and Bacillus cereus var. mycoides,'' 
Journal of Bacteriology, vol. 75, p. 499, 1958, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC290100/pdf/jbacter00512-0024.pdf.
* 8. Buck C.A., R.L. Anacker, F.S. Newman, et al., ``Phage Isolated 
from Lysogenic Bacillus anthracis,'' Journal of Bacteriology, vol. 
85, p. 423, 1963, available at https://jb.asm.org/content/85/6/1423.full.pdf+html?sid=c14df35d-1d7b-4cac-b55b-2097931a4623.
9. Parry, J.M., P.C.B. Turnbull, and J.R. Gibson, ``A Colour Atlas 
of Bacillus Species,'' Wolfe Medical Publications Ltd., London, 
1983.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


[[Page 12088]]



0
2. Section 866.3045 is added to subpart D to read as follows:


Sec.  866.3045   In vitro diagnostic device for Bacillus spp. 
detection.

    (a) Identification. An in vitro diagnostic device for Bacillus 
species (spp.) detection is a prescription device used to detect and 
differentiate among Bacillus spp. and presumptively identify B. 
anthracis and other Bacillus spp. from cultured isolates or clinical 
specimens as an aid in the diagnosis of anthrax and other diseases 
caused by Bacillus spp. This device may consist of Bacillus spp. 
antisera conjugated with a fluorescent dye (immunofluorescent reagents) 
used to presumptively identify bacillus-like organisms in clinical 
specimens; bacteriophage used for differentiating B. anthracis from 
other Bacillus spp. based on susceptibility to lysis by the phage; or 
antigens used to identify antibodies to B. anthracis (anti-toxin and 
anti-capsular) in serum. Bacillus infections include anthrax 
(cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, 
and gastrointestinal disease and non-gastrointestinal infections caused 
by B. cereus.
    (b) Classification. Class II (special controls). The special 
controls are set forth in FDA's special controls guideline document 
entitled ``In Vitro Diagnostic Devices for Bacillus spp. Detection; 
Class II Special Controls Guideline for Industry and Food and Drug 
Administration Staff.'' For availability of the guideline document, see 
Sec.  866.1(e).
    (c) Restriction on Distribution. The distribution of these devices 
is limited to laboratories that follow public health guidelines that 
address appropriate biosafety conditions, interpretation of test 
results, and coordination of findings with public health authorities.
    (d) Restriction on Use. The use of this device is restricted to 
prescription use and must comply with the following:
    (1) The device must be in the possession of:
    (i)(A) A person, or his agents or employees, regularly and lawfully 
engaged in the manufacture, transportation, storage, or wholesale or 
retail distribution of such device; or
    (B) A practitioner, such as a physician, licensed by law to use or 
order the use of such device; and
    (ii) The device must be sold only to or on the prescription or 
other order of such practitioner for use in the course of his 
professional practice.
    (2) The label of the device shall bear the statement ``Caution: 
Federal law restricts this device to sale by or on the order of a __'', 
the blank to be filled with the word ``physician'' or with the 
descriptive designation of any other practitioner licensed by the law 
of the State in which he practices to use or order the use of the 
device.
    (3) Any labeling, as defined in section 201(m) of the Federal Food, 
Drug, and Cosmetic Act, whether or not it is on or within a package 
from which the device is to be dispensed, distributed by, or on behalf 
of the manufacturer, packer, or distributor of the device, that 
furnishes or purports to furnish information for use of the device 
contains adequate information for such use, including indications, 
effects, routes, methods, and frequency and duration of administration 
and any relevant hazards, contraindications, side effects, and 
precautions, under which practitioners licensed by law to employ the 
device can use the device safely and for the purposes for which it is 
intended, including all purposes for which it is advertised or 
represented. This information will not be required on so-called 
reminder-piece labeling which calls attention to the name of the device 
but does not include indications or other use information.
    (4) All labeling, except labels and cartons, bearing information 
for use of the device also bears the date of the issuance or the date 
of the latest revision of such labeling.

    Dated: March 22, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-06026 Filed 3-29-19; 8:45 am]
 BILLING CODE 4164-01-P